MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-36-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Scar Tissue (2060); Synovitis (2094); Unspecified Musculoskeletal problem (4535)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right tha.Subsequently, the patient presented to their surgeon with complaints of pain, stiffness and dissatisfaction.As a result, approximately 10 years and 3 months after initial implantation, the patient underwent a right hip revision.The acetabular liner was noted to be worn and was exchanged along with the femoral head.During surgery the patient was noted to have excess scar tissue, synovitis and ectopic bone growth.No further patient impact reported.
Additional Manufacturer Narrative
D10: (b)(6) 101-45-20 - 4.5mm drill bit 20mm.(b)(6) 170-36-07 - biolox delta femoral head 36mm od, +7mm.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) 186-01-60 - integrip cc, cluster 60mm, g4.(b)(6) 188-01-11 - wedge plasma x/o sz 11.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11 no device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The devices appear unremarkable and do not show obvious signs of prosthesis wear.Radiograph images were provided; however, the reported event was unable to be confirmed.The radiograph provided does not display signs of decentering of the femoral head with respect to the acetabular cup.The radiograph appears unremarkable for signs of liner prosthesis wear.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.The most likely underlying cause for the revision reported is due to the presence of joint pain after being implanted for more than 10 years.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22205108
• Report Number: 1038671-2025-02295
• Device Sequence Number: 7714144
• Product Code: JDI
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male